Prostate Cancer Clinical Trial
MGC018 Versus Androgen Receptor Axis-targeted Therapy in Participants With Metastatic Castration Resistant Prostate Cancer
Study CP-MGC018-03 is a randomized, open-label, seamless, Phase 2/3 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT) and one prior taxane-containing regimen. ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior cabazitaxel regimen, but no other chemotherapy agents.
The Phase 2 stage will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg Q4W and 2.7 mg/kg Q4W) compared to the control arm (abiraterone or enzalutamide). Approximately 150 participants will be randomized 1:1:1 in Phase 2 among the three study treatment arms (two vobramitamab duocarmazine experimental arms and one control arm). An interim analysis will be performed to select the Phase 3 dose regimen for the vobramitamab duocarmazine experimental arm for Phase 3 after approximately 150 participants enrolled in Phase 2 have been followed for at least 2 months (60 days).
The Phase 3 stage will assess efficacy of the selected dose regimen for the vobramitamab duocarmazine experimental arm versus the control arm (abiraterone or enzalutamide). Approximately 270 additional participants will be randomized 1:1 between each study treatment arm in Phase 3 (one vobramitamab duocarmazine experimental arm and the control arm).
Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
Participants must have ≥ 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria
Received 1 prior ARAT for metastatic prostate cancer (mPC) with lack of progression for at least 12 months
Received 1 prior taxane-containing regimen for mPC.
May have received up to 1 prior cabazitaxel regiment for mPC.
Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
Acceptable physical condition and laboratory values.
Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
Prior chemotherapy other than docetaxel or cabazitaxel. Prior immunotherapy and radiopharmaceutical therapy is allowed.
Known history of documented BRCA or ATM mutation (germline or somatic). Participants with known BRCA or ATM mutation who had disease progression or unacceptable toxicity on a PARP inhibitor are eligible.
Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
Untreated, symptomatic central nervous system (CNS) metastasis.
Prior treatment with any B7-H3 targeted agent for cancer,
Contradictions to the use of corticosteroid treatment
Prior stem cell, tissue, or solid organ transplant.
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There are 5 Locations for this study
Orange City Florida, 32763, United States More Info
Covington Louisiana, 70433, United States More Info
Canton Ohio, 44718, United States More Info
Myrtle Beach South Carolina, 29572, United States More Info
Fairfax Virginia, 22031, United States More Info
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